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Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet NIV | Experimental | Patients randomized to the intervention arm will receive NIV through a phthalate free helmet (CaStar, STARMED) via an ICU ventilator in pressure support (PS) mode. |
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| Facemask NIV | Active Comparator | Patients in the control arm will be randomized to the traditional facemask interface. The facemask group will use the same ICU ventilator being used for the helmet group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet Non-Invasive Ventilation | Device | The helmet interface is a modality which is used to deliver NIV to patients with respiratory failure. A transparent hood is placed over the entire head of the patient with a seal at the neck using a soft collar. |
| Measure | Description | Time Frame |
|---|---|---|
| Consent Rate | Percentage of patients or SDMs approached for consent who give consent | 1 year |
| Recruitment Rate | Number of patients recruited to the study per centre | 1 year |
| Protocol adherence percentage | Adherence to pre-specified fixed protocol on how helmet interface is implemented (settings, weaning etc.) Any protocol deviations will be recorded and marked as protocol non-adherence. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Endotracheal intubation | Number of patients requiring endotracheal intubation | 28 days |
| ICU mortality | Number of patients who die in ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bram Rochwerg, MD | Hamilton Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Hospital | Hamilton | Ontario | L8V1C3 | Canada |
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| Facemask Non-Invasive Ventilation | Device | The facemask interface is a modality which is also used to deliver NIV to patients with respiratory failure. A large mask covering the mouth and nose is strapped to the patient's face to create a seal. |
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| 28 days |
| Hospital mortality | Number of patients who die in hospital | 60 days |
| ICU length of stay | Number of days that each patient spends in ICU | Censored at 28 days |
| Hospital length of stay | Number of days that each patients spends in hospital | Censored at 60 days |
| Duration of non-invasive ventilation | Number of days that patient receives non-invasive ventilation | Censored at 28 days |
| Duration of invasive ventilation | Number of days that patient receives invasive ventilation | Censored at 28 days |
| Adverse events | Any complications related to NIV use | 28 days |
| Comfort | Patient comfort with non-invasive ventilation | 28 days |